POLARING

Package leaflet: Information for the user

PolaRing, (0.120 mg + 0.015 mg)/24 h, vaginal therapeutic system
Etonogestrel + Ethinylestradiol
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet

1. What PolaRing is and what it is used for
2. Important information before using PolaRing 2.1 When not to use PolaRing 2.2 Warnings and precautions Blood clots Cancer 2.3 Children and adolescents 2.4 PolaRing with other medicines Diagnostic tests 2.5 Pregnancy and breastfeeding 2.6 Driving and operating machinery
3. How to use PolaRing 3.1 Insertion and removal of PolaRing 3.2 Three weeks of use, one week break 3.3 When to insert the first PolaRing vaginal ring 3.4 What to do if… Managing accidental expulsion of the system from the vagina Managing when the system has been outside the vagina for some time Managing if the vaginal therapeutic system is damaged Managing if more than one vaginal therapeutic system has been inserted Managing if, after the weekly break, the user forgot to insert a new vaginal therapeutic system Managing if the user forgot to remove the vaginal therapeutic system Managing if there is no bleeding Managing if unexpected bleeding occurs Managing if the day of bleeding changes Managing if delaying bleeding is desired 3.5 What to do if the user wishes to stop using PolaRing
4. Possible side effects
5. How to store PolaRing
6. Contents of the pack and other information What PolaRing contains What PolaRing looks like and contents of the pack Marketing authorisation holder and manufacturer

1. What PolaRing is and what it is used for

PolaRing is a contraceptive medicine in the form of a vaginal therapeutic system that prevents pregnancy. Each vaginal therapeutic system contains a small amount of two female sex hormones – etonogestrel and ethinylestradiol. These hormones are slowly released from the system into the bloodstream. Due to the low dose of hormones released, PolaRing is classified as a low-dose hormonal contraceptive. Since PolaRing releases two different hormones, it is also referred to as a combined hormonal contraceptive.
PolaRing works similarly to a combined oral contraceptive pill (combined pill). However, unlike a pill that must be taken daily, PolaRing is used continuously for 3 weeks. PolaRing releases two female sex hormones that inhibit the release of eggs from the ovaries. Because eggs are not released, the user cannot become pregnant.

2. Important information before using PolaRing

General notes
Before starting to use PolaRing, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2, "Blood clots").
This leaflet describes situations in which you should stop using PolaRing or when its effectiveness may be reduced. In these situations, you should avoid sexual intercourse or use an additional non-hormonal contraceptive method, such as a condom or another mechanical method. Do not use calendar-based methods or body temperature monitoring. These methods may be ineffective because PolaRing affects changes in body temperature and cervical mucus consistency throughout the month.
PolaRing, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted infections.

2.1 When not to use PolaRing

Do not use PolaRing if the patient has any of the conditions listed below. If any of these conditions apply, the patient must inform her doctor. The doctor will discuss with the patient which alternative contraceptive method would be more suitable.

• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs,

• if the patient knows she has blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies,

• if the patient requires surgery or will be immobile for a prolonged period (see section “Blood clots”),

• if the patient has had a heart attack or stroke,

• if the patient has (or has previously had) angina pectoris (a condition causing severe chest pain and may be an early sign of heart attack) or transient ischaemic attack (temporary stroke-like symptoms),

• if the patient has any of the following diseases that may increase the risk of arterial blood clot:

  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia

• if the patient currently has (or has previously had) a type of migraine called “migraine with aura”,

• if the patient currently has or has previously had pancreatitis associated with high fat levels in the blood,

• if the patient currently has or has previously had severe liver disease and liver function has not returned to normal,

• if the patient currently has or has previously had a benign or malignant liver tumour,

• if the patient currently has or has previously had breast cancer or genital organ cancer, or if such cancers are suspected,

• if the patient has unexplained vaginal bleeding,

• if the patient is allergic to ethinylestradiol or etonogestrel or to any of the other ingredients of this medicine (listed in section 6).

If any of the above symptoms occur for the first time during use of PolaRing, the device must be immediately removed from the vagina and the patient should consult a doctor. During this time, a non-hormonal contraceptive method should be used.

Do not use PolaRing if the patient has hepatitis C and is taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section 2.4 “PolaRing and other medicines”).

2.2 Warnings and precautions

When should you contact a doctor?
You should seek medical advice immediately

• if the patient experiences symptoms suggestive of blood clots, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots"). For a description of the symptoms of these serious adverse reactions, see "How to recognize the occurrence of blood clots".

Tell your doctor if the patient has any of the following conditions.
If any of these conditions appear or worsen during treatment with PolaRing, you should also
inform your doctor.

• if breast cancer is currently present or has occurred in close family members;

• if the patient has epilepsy (see section 2.4 "PolaRing and other medicines");

• if the patient has liver disease (e.g. jaundice) or gallbladder disease (e.g. gallstones);

• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);

• if the patient has systemic lupus erythematosus (a disease affecting the body's natural defense system);

• if the patient has hemolytic uremic syndrome (a blood clotting disorder causing kidney failure);

• if the patient has sickle cell anemia (an inherited disorder of red blood cells);

• if the patient has high levels of fats in the blood (hypertriglyceridemia) or a positive family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;

• if the patient requires surgery or will be immobile for a prolonged period (see section 2 "Blood clots");

• if the patient is in the immediate postpartum period, as she is then at increased risk of developing blood clots. Consult a doctor to determine how soon after delivery PolaRing treatment can be started;

• if the patient has phlebitis (inflammation of superficial veins under the skin);

• if the patient has varicose veins;

• if the patient has conditions that first occurred or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria [a blood disorder], herpes gestationis [blistering skin rash during pregnancy], Sydenham's chorea [a nervous system disorder characterized by involuntary, violent movements]);

• if the patient currently has or has previously had chloasma (yellow-brown pigmented patches, so-called "melasma" or "pregnancy mask," especially on the face). If such patches occur, excessive sun exposure and ultraviolet radiation should be avoided;

• if the patient has conditions that make the use of PolaRing difficult, such as frequent constipation, uterine prolapse, or pain during intercourse;

• if the patient experiences sudden, frequent urges to urinate accompanied by a burning sensation and/or pain, or if the patient cannot locate the intravaginal therapeutic system inside the vagina. These symptoms may indicate accidental placement of the PolaRing intravaginal system into the urinary bladder;

• if the patient develops symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria with potential breathing difficulties, medical advice must be sought immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
The use of combined hormonal contraceptives, such as the PolaRing intravaginal system, is associated with an increased risk of blood clots compared to not using such treatment. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease")
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
It should be remembered that the overall risk of harmful blood clots associated with the use of PolaRing is low.
HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek medical advice immediately if any of the following symptoms occur.
Is the patient experiencing any of these symptoms? What might be the likely cause?
What might the patient be suffering from?

BLOOD CLOTS IN VEINS
What can happen if blood clots form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots the highest?
The risk of developing venous blood clots is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a patient stops using PolaRing, the risk of blood clots returns to normal within a few weeks.

What does the risk of venous blood clots depend on?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with using PolaRing is low.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 6 to 12 out of 10,000 women who use combined hormonal contraceptives containing ethinylestradiol or etonogestrel, such as the PolaRing vaginal contraceptive system, will develop blood clots.
• The risk of developing blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of the vaginal therapeutic system PolaRing is small, but certain factors may increase this risk. The risk is higher:

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years of age). In such a case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue use of PolaRing several weeks before surgery or during periods of limited mobility. If the patient must stop using PolaRing, consult the doctor about when it is safe to resume use;
• with increasing age (especially over 35 years);
• if the patient has given birth within the last few weeks.

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if the patient has any other listed risk factor.
It is important to inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue use of PolaRing.
Inform the doctor if any of the above conditions change during treatment with PolaRing, for example, if a close family member is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can cause serious consequences, such as heart attack or stroke.

Factors increasing the risk of blood clots in arteries
It is important to emphasize that the risk of heart attack or stroke associated with the use of the vaginal therapeutic system PolaRing is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as the vaginal therapeutic system PolaRing, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In such a case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac arrhythmia such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with the vaginal therapeutic system PolaRing, for example, if the patient starts smoking, a close family member is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.

Cancer
The following information is based on studies of combined oral contraceptives and may also apply to PolaRing. Data regarding vaginal use of hormonal contraceptives (as with PolaRing) are not available.
Among women using combined hormonal contraceptives, a slightly increased incidence of breast cancer has been observed, although it is not known whether this is caused by the medication. It is possible that breast cancer is detected more frequently in these women because they undergo medical examinations more regularly. The increased incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
Regular breast examination is very important. If any lump is detected, consult a doctor immediately. The doctor should also be informed if any close relatives have had or currently have breast cancer (see section 2.2 "Warnings and precautions").
Rarely, benign liver tumors and, very rarely, malignant liver tumors have occurred in women using combined hormonal contraceptives. If unusual, severe abdominal pain occurs, contact the doctor immediately.
There are reports that women using combined hormonal contraceptives have a lower incidence of endometrial cancer (cancer of the lining of the uterus) and ovarian cancer. This may also apply to PolaRing, but this has not yet been confirmed.

Psychiatric disorders
Some women using hormonal contraceptives, including PolaRing, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor as soon as possible for further medical advice.

2.3 Children and adolescents

The safety and efficacy of PolaRing have not been studied in children and adolescents under 18 years of age.

2.4 PolaRing and other medicines

Always inform your doctor about any medicines or herbal products you are currently using.
You should also inform any specialist doctor, dentist or pharmacist who prescribes other medicines
about your use of PolaRing. They may advise you whether additional contraceptive methods
(e.g. male condoms) are needed, how long they should be used, and whether any adjustment
in the use of other medicines is required.
Some medicines:

• may affect the blood levels of PolaRing
• may reduce its contraceptive effectiveness
• may cause unexpected bleeding.

This applies to medicines used in the treatment of:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g. rifampicin);
• HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C virus infection (e.g. boceprevir, telaprevir);
• other infectious diseases (e.g. griseofulvin);
• pulmonary arterial hypertension (bosentan);
• depressive disorders (St. John's wort, Hypericum perforatum).

If you are taking medicines or herbal products that may reduce the effectiveness of PolaRing,
you should also use a mechanical contraceptive method (e.g. male condoms). Because the effect
of another medicine on PolaRing may persist for up to 28 days after stopping the medicine,
additional mechanical contraception should be used during this period.
Note: PolaRing should not be used with a diaphragm, cervical cap or female condom.
PolaRing may affect the action of other medicines, such as:

• medicines containing cyclosporine
• the anticonvulsant lamotrigine (which may lead to increased frequency of seizures).

PolaRing must not be used if you have hepatitis C and are taking medicines containing
ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir,
or sofosbuvir with velpatasvir and voxilaprevir, as these may cause abnormal liver function test results
detected in blood tests (increased ALT activity).
Your doctor will prescribe another type of contraception before starting treatment with these medicines.
PolaRing may be used again approximately 2 weeks after completion of treatment with these medicines
(see section 2.1 "When not to use PolaRing").
Before taking any medicine, consult your doctor or pharmacist.
During use of PolaRing, tampons may be used. Insert PolaRing before inserting a tampon.
Be careful when removing the tampon to avoid accidentally removing PolaRing as well.
If PolaRing comes out, rinse the vaginal ring under cold or lukewarm water and reinsert it as soon as possible.
Damage to the vaginal ring has occurred during use of vaginal products such as lubricants or treatments for infections
(see section 3.4 "What to do if the vaginal ring is damaged").
The use of spermicides or vaginal antifungal medicines does not reduce the contraceptive effectiveness of PolaRing.
Diagnostic tests
If laboratory tests of blood or urine are to be performed, inform the healthcare personnel that you are using PolaRing,
as use of the vaginal ring may affect the results of certain laboratory tests.

2.5 Pregnancy and breast-feeding

PolaRing must not be used during pregnancy or if there is suspicion that a woman might be pregnant. If a patient becomes pregnant while using PolaRing, the vaginal ring should be removed and the patient should contact her physician.
If a patient wishes to discontinue using PolaRing because she intends to become pregnant, refer to section 3.5 "Instructions when a patient wishes to discontinue using PolaRing".
The use of PolaRing during breast-feeding is not recommended. If a patient wishes to use PolaRing while breast-feeding, she should consult her physician first.

2.6 Driving and operating machinery

PolaRing does not affect the ability to drive vehicles or operate machinery.

3. How to use PolaRing

This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
PolaRing can be inserted and removed by yourself. Your doctor will advise you when to start using
PolaRing for the first time. The vaginal ring must be inserted on the correct day of the cycle (see section 3.3 "When to insert the first vaginal ring")
and left in place continuously for 3 weeks. You should regularly check that the PolaRing vaginal ring is in place (e.g. before and after sexual intercourse) to ensure
you are protected against pregnancy. After 3 weeks, remove PolaRing and take a 1-week break.
Withdrawal bleeding usually occurs during this treatment-free week.
Do not use certain mechanical contraceptive methods for women, such as a diaphragm, cervical cap, or female condom, while using PolaRing. These mechanical contraceptive methods should not be used as additional contraception, because PolaRing may interfere with the correct placement and positioning of an intrauterine device, cervical cap, or female condom. However, a male condom may be used as an additional mechanical contraceptive method.

3.1 Insertion and removal of PolaRing

1. Before inserting the system, check the expiry date (see section 5, "How to store PolaRing").
2. Wash your hands before inserting or removing the system.
3. Choose the most comfortable position for insertion, such as standing with one leg raised, squatting, or lying down.
4. Remove PolaRing from the pouch. Keep the pouch for later use.
5. Holding the system between your thumb and index finger, squeeze it together and insert into the vagina (see Figures 1–4). PolaRing should be positioned so that it is not felt. If the system causes discomfort, gently push it further into the vagina. The exact position within the vagina does not affect its contraceptive efficacy.
6. After three weeks, remove the system from the vagina by hooking your index finger under the edge of the system or grasping it between your index and middle fingers and pulling it out (Figure 5). If the user can locate the system in the vagina but is unable to remove it, she should contact her doctor.
7. Dispose of the used system with household waste, preferably inside the pouch. Do not flush PolaRing down the toilet.

Figure 1
Remove the system from the pouch

Figure 2 Squeeze the system

Figure 3
Choose the most comfortable position for inserting the system

Figure 4A Figure 4B Figure 4C
Insert the system into the vagina with one hand (Figure 4A), spreading the labia with the other hand if necessary. Place it inside the vagina in a comfortable position (Figure 4B). Leave the system in the vagina for 3 weeks (Figure 4C).

Figure 5
Remove PolaRing from the vagina by hooking your index finger under the edge of the system or grasping it between your index and middle fingers and pulling it out.

3.2 Three weeks of use, one week break

1. The system must remain in the vagina continuously for three weeks, starting from the day of insertion.
2. After three weeks, it must be removed on the same day of the week and approximately at the same time as it was inserted. For example, if PolaRing was inserted on a Wednesday around 10:00 PM, it should be removed also on a Wednesday, three weeks later, around 10:00 PM.
3. After removal of the system, a one-week break should be taken. During this time, bleeding may occur. It usually begins 2-3 days after removal of PolaRing.
4. A new system must be inserted exactly one week after the previous one was removed (on the same day of the week and approximately at the same time), even if bleeding is still ongoing.

If insertion of the new system is delayed by more than 3 hours, contraceptive effectiveness may be reduced. In such a case, follow the instructions provided in section 3.4 "Procedure if, after the weekly break, the patient has forgotten to insert a new vaginal therapeutic system".
If PolaRing is used according to the above recommendations, subsequent bleedings will occur each month on approximately the same days of the week.

3.3 When to insert the first vaginal ring system

• No hormonal contraceptive was used in the previous month

Insert the first PolaRing on the first day of the natural cycle (i.e. the first day of menstruation). PolaRing is effective from the moment of insertion. There is no need to use any additional contraceptive methods.

PolaRing may also be started between days 2 and 5 of menstruation; however, in this case, an additional contraceptive method (such as a condom) must be used during the first 7 days of PolaRing use. This recommendation applies only when PolaRing is used for the first time.

• The patient has previously used combined oral contraceptive tablets

Begin using PolaRing no later than the day following the break from the currently used contraceptive. If the current contraceptive also includes inactive (placebo) tablets, PolaRing should be started no later than the day after taking the last inactive tablet. In case of doubt about which tablet is the correct one, consult a doctor or pharmacist. Never extend the break from the current tablets beyond the recommended period. If the patient has taken her tablets regularly and is certain she is not pregnant, she may stop taking the tablets on any day and immediately start using PolaRing.

• The patient has previously used a transdermal contraceptive patch

Begin using PolaRing no later than the day following the patch-free interval. Never extend the break from the transdermal system beyond the recommended period. If the patient has used the transdermal system regularly and is certain she is not pregnant, she may discontinue the patch at any time and immediately start using PolaRing.

• The patient has previously used a progestogen-only contraceptive (mini-pill)

The mini-pill may be discontinued at any time, and PolaRing should be inserted the following day at the same time the mini-pill was usually taken. An additional contraceptive method (such as a condom) must be used during the first 7 days of PolaRing use.

• The patient has previously used progestogen-only injections, an implant, or an intrauterine system (IUS) releasing progestogen

Begin using PolaRing on the day of the next scheduled injection, or on the day of removal of the implant or the progestogen-releasing intrauterine system. An additional contraceptive method (such as a condom) must be used during the first 7 days of PolaRing use.

• After childbirth

After childbirth, the doctor may recommend starting PolaRing only after the first menstruation. Sometimes it may be possible to start PolaRing earlier; the doctor will advise when. If breastfeeding and considering using PolaRing, this should first be discussed with a doctor.

• After miscarriage

As directed by the doctor.

3.4 What to do if…

Management in case of accidental expulsion of the system from the vagina
PolaRing may accidentally fall out of the vagina, for example, if it was incorrectly inserted, during tampon removal, during sexual intercourse, in case of constipation, or due to uterine prolapse. Therefore, it is important to regularly check whether the system is still in place (e.g. before and after sexual intercourse).
Management if the system has been outside the vagina for some time
The PolaRing system may still provide protection against pregnancy, but this depends on how long it was outside the vagina.
If the system has been outside the vagina for:

• less than 3 hours, the patient is still protected against pregnancy. The vaginal therapeutic system should be washed with cold or lukewarm (not hot) water and reinserted as soon as possible, but only if it was outside the vagina for less than 3 hours.
• more than 3 hours during the first or second week of use, contraceptive effectiveness may have decreased. The vaginal therapeutic system should be washed with cold or lukewarm (not hot) water and reinserted as soon as possible, and left in place continuously for at least 7 days. If the patient has sexual intercourse during these 7 days, a male condom should additionally be used. If the patient is in the first week of her cycle and has had intercourse during the past 7 days, there is a possibility she may be pregnant. In this case, she should contact her doctor.
• more than 3 hours during the third week of use, contraceptive effectiveness may have decreased. The vaginal therapeutic system should be removed, and one of the following two options should be chosen:
  1 – Insert a new vaginal therapeutic system as soon as possible. Inserting a new system means starting the next three-week period of use. This may prevent the expected withdrawal bleeding, although mid-cycle bleeding or spotting may occur.
  2 – Do not reinsert a vaginal therapeutic system. Wait for withdrawal bleeding to occur and insert a new vaginal therapeutic system no later than 7 days after removal or expulsion of the previous one. This approach is only acceptable if the patient has used PolaRing continuously for the last 7 days.
• If the system has been outside the vagina for an unknown duration, contraceptive effectiveness may have decreased. A pregnancy test should be performed and the patient should contact her doctor before inserting another system.

Management in case of damage to the vaginal therapeutic system
PolaRing may become damaged. Vaginal wall injury associated with damage to the vaginal therapeutic system has been reported. If the patient notices that PolaRing is damaged, she should remove it and insert a new one as soon as possible. For the next 7 days, an additional contraceptive method (e.g. male condom) should be used. If sexual intercourse occurred before the damage was noticed, the patient should contact her doctor.

Management in case of inserting more than one vaginal therapeutic system
There have been no reports of serious adverse effects related to overdose of the hormones contained in PolaRing. If more than one vaginal therapeutic system is accidentally inserted, nausea, vomiting, or vaginal bleeding may occur. The additional vaginal therapeutic system should be removed, and the patient should contact her doctor if symptoms do not resolve.

Management if the patient forgets to insert a new vaginal therapeutic system after the 7-day break
If the break in use of the vaginal therapeutic system was longer than 7 days, a new system should be inserted as soon as possible. If sexual intercourse occurs during the following 7 days, an additional contraceptive method (e.g. male condom) should be used. If sexual intercourse occurred during the break in use of the vaginal therapeutic system, there is a possibility of pregnancy. In such a case, the patient should contact her doctor as soon as possible. The longer the break in use of the vaginal therapeutic system, the higher the likelihood of pregnancy.

Management if the patient forgets to remove the vaginal therapeutic system

• If the system remained in the vagina for longer than 3 weeks but not more than 4 weeks, the patient is still protected against pregnancy. The vaginal therapeutic system should be removed for one week, and then a new one inserted.
• If the patient used the vaginal therapeutic system for longer than 4 weeks, there is a possibility of pregnancy. The patient should contact her doctor before inserting a new vaginal therapeutic system.

Management in case of absence of bleeding

• If the patient used PolaRing according to instructions
  If withdrawal bleeding does not occur on schedule, but the patient used PolaRing as directed and did not take any other medications during this time, the likelihood of pregnancy is very low. The patient should continue using PolaRing as before. However, if withdrawal bleeding does not occur for two consecutive cycles, pregnancy is possible. The patient should contact her doctor as soon as possible. A new PolaRing system should not be inserted until the doctor confirms the patient is not pregnant.
• If the patient used PolaRing incorrectly
  If withdrawal bleeding does not occur during the first break in using PolaRing, and the patient used the vaginal therapeutic system incorrectly, she may be pregnant. The patient should contact her doctor before using a new PolaRing.

Management in case of unexpected bleeding
During use of the vaginal therapeutic system, some women may experience unexpected mid-cycle bleeding. The patient may need sanitary pads. The system should remain in the vagina and be used as usual. If irregular bleeding increases in intensity or recurs, the patient should contact her doctor.

Management in case of changing the day of bleeding occurrence
If PolaRing is used as directed, menstrual periods (withdrawal bleeds) will occur during the weekly break in use of the vaginal therapeutic system. If the patient wishes for withdrawal bleeding to start on a different day, she may shorten the break in use (but never extend it!).
For example: if withdrawal bleeding usually starts on Friday, and the patient wants to shift it to Tuesday (3 days earlier) next month, she should insert the new vaginal therapeutic system 3 days earlier than usual.
If the break in use of the vaginal therapeutic system is significantly shortened (e.g. to 3 days or less), withdrawal bleeding may not occur at all. During use of the next vaginal therapeutic system, spotting (small drops or stains of blood) or mid-cycle bleeding may occur.
If the patient is unsure about what to do, she should consult her doctor.

Management if wishing to delay the onset of bleeding
Although not recommended, it is possible to delay the onset of menstruation (withdrawal bleeding) by inserting a new vaginal therapeutic system immediately after removing the previous one, without taking a break.
The new vaginal therapeutic system should not be used for longer than 3 weeks. During use of the new system, spotting (small drops or stains of blood) or mid-cycle bleeding may occur. To induce bleeding, the vaginal therapeutic system should be removed.
A regular weekly break between consecutive systems is recommended.
Before deciding to delay menstruation, the patient may consult her doctor.

3.5 What to do if the patient wishes to discontinue use of PolaRing

PolaRing may be discontinued at any time.
If the patient does not wish to become pregnant, she should consult her doctor regarding alternative contraceptive methods.
If the patient discontinues use of Pola游戏副本ing because she wishes to become pregnant, she should
wait until her first menstrual period after removal and only then start trying to conceive. This will assist
in determining the due date.

4. Possible adverse effects

Like all medicines, this product may cause adverse effects, although not everyone experiences them.
If any adverse effects occur, especially severe or persistent ones, or any changes in health that the patient considers related to the use of PolaRing, medical advice should be sought immediately.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using PolaRing".

Immediate medical attention is required if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty in swallowing, or urticaria potentially associated with breathing difficulties (see also section "Warnings and precautions").

Women using a vaginal contraceptive system containing etonogestrel and ethinylestradiol have reported the following adverse effects:

Common: may affect up to 1 in 10 women

• Abdominal pain, nausea
• Vaginal fungal infections (such as "thrush"); discomfort due to the presence of the system in the vagina; genital itching; vaginal discharge
• Headache or migraine headache; depressive mood; decreased libido
• Breast pain; pelvic pain; painful menstruation
• Acne
• Weight gain
• Expulsion of the system

Uncommon: may affect up to 1 in 100 women

• Visual disturbances; dizziness
• Bloating; vomiting, diarrhoea or constipation
• Feeling of fatigue, malaise or restlessness; mood changes; sudden mood swings
• Oedema
• Urinary bladder or urinary tract infections
• Problems or pain during urination; urgency or need to urinate; frequent urination
• Discomfort during intercourse, including pain, bleeding, or discomfort due to the presence of the system felt by the partner
• Increased blood pressure
• Increased appetite
• Back pain; muscle cramps; pain in lower or upper limbs
• Decreased skin sensitivity
• Breast tenderness or enlargement; fibrocystic breast disease (cysts which may cause breast swelling or pain)
• Cervicitis; cervical polyps; cervical ectropion
• Changes in menstrual bleeding (e.g. heavy, prolonged, irregular or complete absence of menstruation); pelvic discomfort; premenstrual syndrome; uterine cramps
• Vaginal infections (fungal or bacterial); burning sensation, unpleasant odour, pain, discomfort or dryness of the vagina or vulva
• Hair loss, rash, itching, skin eruptions or hot flushes
• Urticaria

Rare: may affect up to 1 in 1,000 women

• Harmful blood clots in a vein or artery, for example:
  • in the leg or foot (e.g. deep vein thrombosis)
  • in the lungs (e.g. pulmonary embolism)
  • heart attack
  • stroke
  • mini-stroke or transient ischaemic attack (TIA)
  • blood clots in the liver, stomach, intestines, kidneys or eye

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of their occurrence).

• Discharge from the breast

Unknown frequency (cannot be estimated from available data)

• Chloasma (yellowish-brown pigmented patches on the skin, especially on the face)
• Partner's discomfort during intercourse (such as irritation, rash, itching)
• Inability to remove the vaginal contraceptive system without medical assistance (e.g. due to adhesion of the vaginal system to the vaginal wall)
• Vaginal wall injury related to damage of the vaginal contraceptive system

Breast cancer and liver tumours have been reported in women using combined hormonal contraceptives. For detailed information, see section 2.2 "Warnings and precautions", "Tumours".

PolaRing may become damaged. For additional information, see section 3.4 "Management in case of damage to the vaginal contraceptive system".

Reporting of adverse effects

If any adverse effects occur, including those not listed in this leaflet, inform a doctor or pharmacist.

Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorisation holder.

Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store PolaRing

The medicine should be kept out of the sight and reach of children.
Contact a doctor if a child is suspected to have been exposed to the hormones contained in PolaRing.
There are no special storage temperature requirements for this medicine. Store in the original packaging to protect from light.
PolaRing should be inserted at least one month before the expiry date stated on the box and on the sachet after EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation "EXP" indicates the expiry date, and after the abbreviation "Lot" indicates the batch number.
Do not use PolaRing if you notice any change in colour or if there are any signs of damage.
This medicine may pose a risk to the environment. After removal, PolaRing should be placed in the sachet and carefully sealed. The sealed sachet should be disposed of with household waste or returned to a pharmacy for proper destruction in accordance with local regulations.
PolaRing must not be flushed down the toilet. As with other medicines, unused or expired systems should not be disposed of via sewage or household waste bins. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Contents of the pack and other information

What PolaRing contains

• The active substances are: etonogestrel (8.25 mg) and ethinylestradiol (2.60 mg). The vaginal therapeutic system releases etonogestrel and ethinylestradi0l at daily doses of 0.120 mg and 0.015 mg, respectively, over a period of 3 weeks.
• Other components: ethylene and vinyl acetate copolymer (28% vinyl acetate), polyurethane (a type of synthetic polymer which does not dissolve in the body).

What PolaRing looks like and contents of the pack
Vaginal therapeutic system.
PolaRing is a soft, transparent, colourless or almost colourless ring with an outer diameter of 54 mm. The cross-sectional diameter of the ring is 4 mm.
Each vaginal therapeutic system is individually packed in an aluminium sachet. The sachets are contained in a cardboard box together with the package leaflet.
Adhesive labels are included in the package. When attached to the appropriate day on a calendar, they help remind you when to insert and remove the PolaRing vaginal therapeutic system.
Pack sizes contain 1, 3 or 6 systems.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
Laboratorios León Farma, S.A.
Calle La Vallina s/n, Poligono Industrial Navatejera
24193- Villaquilambre, León
Spain